Antiretroviral Agents in HIV-1 (trial)

DHHS Adult HIV 2013

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6 Selecting a Treatment Regimen Table 4. Antiretroviral Regimens or Components That Should NOT Be Offered at Any Time ARV Drugs or Components (in alphabetical order) Reasons for NOT Recommending as Initial Therapy ABC/3TC/ZDV (coformulated) as triple- NRTI combination regimen (BI) ▶ Inferior virologic efficacy ABC + 3TC + ZDV + TDF as quadruple-NRTI combination (BI) ▶ Inferior virologic efficacy ABC + ddI (BIII) ▶ Insufficient data in ART-naive patients ABC + TDF (BIII) ▶ Insufficient data in ART-naive patients d4T + 3TC (BI) ▶ Significant toxicities including lipoatrophy; peripheral neuropathy; and hyperlactatemia, including symptomatic and life-threatening lactic acidosis, hepatic steatosis, and pancreatitis ddI + 3TC (or FTC) (BIII) ▶ Inferior virologic efficacy, least clinical trial experience ddI + TDF (BII) ▶ High rate of early virologic failure ▶ Rapid selection of resistance mutations ▶ Potential for immunologic nonresponse/CD4 T-cell decline ▶ Increased ddI drug exposure and toxicities DLV (BII) ▶ Inferior virologic efficacy ▶ Inconvenient (three times daily) dosing DRV (unboosted) ▶ Use without RTV has not been studied ENF (BIII) ▶ No clinical trial experience in ART-naive patients ▶ Requires twice-daily subcutaneous injections ETR (BIII) ▶ Insufficient data in ART-naive patients FPV (unboosted) (BIII) ▶ Less potent than RTV-boosted FPV ▶ Virologic failure with unboosted FPV-based regimen may select mutations that confer resistance to DRV IDV (unboosted) (BIII) ▶ Inconvenient dosing (three times daily with meal restrictions) ▶ Fluid requirement IDV (RTV-boosted) (BIII) ▶ High incidence of nephrolithiasis NFV (BI) ▶ Inferior virologic efficacy ▶ High incidence of diarrhea RTV as sole PI (BIII) ▶ High pill burden ▶ Gastrointestinal intolerance SQV (unboosted) (BI) ▶ Inferior virologic efficacy TPV (RTV-boosted) (BI) ▶ Inferior virologic efficacy

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